Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
moxonidine, Quantity: 200 microgram
Southern Cross Pharma Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; lactose monohydrate; crospovidone; povidone; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red; macrogol 400
Oral
30, 10, 14, 28, 100, 98, 84, 56, 60
(S4) Prescription Only Medicine
APO-MOXONIDINE (moxonidine tablets) is indicated for the treatment of hypertension.
Visual Identification: Pink round biconvex film coated tablets 5 mm in diameter; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2018-01-16
APO-MOXONIDINE 1 APO-MOXONIDINE TABLETS _moxonidine _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APO-Moxonidine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking APO- Moxonidine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT APO-MOXONIDINE IS USED FOR APO-Moxonidine is used to lower high blood pressure, which is sometimes called hypertension. Everyone has blood pressure. This pressure helps to move your blood around your body. Your blood pressure may change at different times of the day. You have hypertension when your blood pressure stays higher than normal, even when you are calm or relaxed. There are usually no symptoms of hypertension. The only way of knowing if you have hypertension is to have your blood pressure checked regularly. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for children under the age of 16 years. BEFORE YOU TAKE APO- MOXONIDINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE APO-MOXONIDINE IF YOU HAVE AN ALLERGY TO: • any medicine containing moxonidine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the Læs hele dokumentet
AUSTRALIAN PRODUCT INFORMATION APO-MOXONIDINE ® TABLETS _ _ 1. NAME OF THE MEDICINE Moxonidine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION APO-MOXONIDINE tablets are immediate release film-coated tablets for oral use containing 0.2 mg or 0.4 mg moxonidine. Excipient with known effect: Sugars (as lactose monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM APO-MOXONIDINE 0.2 mg tablets: pink round biconvex film coated tablets 5 mm in diameter. APO-MOXONIDINE 0.4 mg tablets: pink round biconvex film coated tablets 7 mm in diameter. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS APO-MOXONIDINE is indicated for the treatment of hypertension. 4.2. DOSE AND METHOD OF ADMINISTRATION Treatment should be started with 0.2 mg APO-MOXONIDINE in the morning. The dose may be titrated after two weeks to 0.4 mg given as one dose or as divided doses (morning and evening) until a satisfactory response is achieved. If the response is still unsatisfactory after a further 2 weeks treatment, the dosage can be increased up to a maximum of 0.6 mg in divided doses (morning and evening). A single daily dose of 0.4 mg and a divided daily dose of 0.6 mg of APO-MOXONIDINE should not be exceeded. APO-MOXONIDINE may be taken with or without food. RENAL IMPAIRMENT In patients with moderate renal impairment (GFR 30 – 60 mL/min), the single dose should not exceed 0.2 mg and the daily dose should not exceed 0.4 mg of moxonidine. USE IN ELDERLY See Sections 4.3 Contraindications and 5.2 Pharmacokinetic Properties - Pharmacokinetics in the Elderly. 4.3. CONTRAINDICATIONS Hypersensitivity to any of the ingredients (see Section 6.1 List of excipients). Heart failure (NYHA Class I – IV). Patients aged 75 years or older (see Section 5.2 Pharmacokinetic properties - Pharmacokinetics in the elderly). APO- MOXONIDINE – AUSTRALIAN PRODUCT INFORMATION 2 Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia, including sick sinus syndrome, or second or third degree atrioventricular (AV) b Læs hele dokumentet